TB-TST (TB treatment support tools): Refinement and evaluation of an interactive mobile app and direct adherence monitoring on TB treatment outcomes

项目总结 这项研究的总体目标是改进结核病(TB)治疗支持工具(TB-TST)干预，该干预将使用 以用户为中心的设计原则和纸质药物代谢物尿液试纸改装成家用，以改善治疗结果 并通过随机对照试验评价其影响。结核病是一个紧迫的全球健康威胁，也是世界上最致命的传染病 基本上是可以治愈的。对结核病治疗方案的药物依从性差，以及在监测患者和让他们接受治疗方面的挑战， 是导致不良结局和耐药性发展的重要因素。结核病患者面临着多个向善的障碍 坚持治疗，如药物副作用、耻辱以及缺乏关于疾病及其治疗的教育。随着技术进步，以及 随着移动技术平台的激增，人们对可能使用移动健康(MHealth)干预措施来解决 这些挑战。在正在调查的监测结核病依从性的mHealth方法中，药物代谢物测试已被确定为 与其他移动解决方案(例如视频)相比，最有前途、最合乎道德、最准确、最不具侵入性和污名化的策略 观察，“智能”药瓶，可食用传感器)，但其潜力在很大程度上仍未被开发。此外，移动应用程序(APP) 可以提供个性化的治疗监督，增加患者的自我管理，并通过提供 更高级的患者支持和监控功能。然而，现有的结核病相关应用程序并没有将患者作为最终目标- 用户也没有得到充分的评估。这项建议建立在前期工作的基础上，1)结合患者和专家的意见，迭代地 设计治疗支持应用程序的内容、特性、功能和界面，2)优化纸质测试条，用于测试 尿中存在异烟肼药物代谢物，以直接监测治疗依从性。TB-TST应用程序的现有版本具有 以下功能：它提供关于结核病及其治疗的教育，与护理协调员沟通，跟踪治疗依从性(通过 自我报告和直接代谢物试纸图像)，自我报告治疗副作用，并保留患者的“日记”记录。结果来自于 这一版本的试行测试将是这项拟议研究的起点。目的是：1)在前期研究的基础上完善结核病-TST干预措施 以用户为中心设计的发现和应用原则；2)评估TB-TST对治疗结果(成功、默认)的影响 常规护理；3)评估患者和提供者对促进者的看法以及实施TB-TST的障碍，并总结经验教训 向利益攸关方和政策制定者学习。主要结果将是治疗成功。次要结果将包括：默认治疗 费率、自我报告的遵从性、技术使用和可用性。研究结果不仅对结核病依从性有更广泛的影响，对疾病也有更广泛的影响 更广泛的管理，将提高我们对如何支持面临挑战的治疗方案的患者的理解。

PROJECT SUMMARY The overall goal of this study is to refine the tuberculosis (TB) treatment support tools (TB-TST) intervention, which links an app developed using user-centered design principles and a paper-based drug metabolite urine test strip modified for home use, to improve treatment outcomes for patients with TB, and evaluate its impact by a RCT. TB is an urgent global health threat and the world's deadliest infectious disease despite it being largely curable. Poor medication adherence to TB regimens, along with challenges in monitoring patients and returning them to treatment, are important contributing factors to poor outcomes and the development of drug resistance. Individuals with TB face multiple barriers to good treatment adherence such as medication side effects, stigma, and lack of education about the disease and its treatment. With advances in, and proliferation of, mobile technology platforms, there is substantial interest in the possible use of mobile health (mHealth) interventions to address these challenges. Of the mHealth approaches under investigation for TB adherence monitoring, drug metabolite testing has been identified as the most promising, ethical, and accurate, and the least intrusive and stigmatizing strategy compared to other mobile solutions (eg, video observation, “smart” medication bottles, ingestible sensor), yet its potential remains largely unexplored. Additionally, mobile applications (apps) may provide personalized treatment supervision, increase patients' self-management and improve patient-provider communication by offering more advanced functionalities for patient support and monitoring. However, available TB-related apps have not focused on patients as the end- users nor have they been fully evaluated. This proposal builds on preliminary work to 1) combine input from patients and experts to iteratively design the content, features, functionalities, and interface of the treatment support app and 2) optimize a paper-based test strip for testing the presence of isoniazid drug metabolites in urine to directly monitor adherence to treatment. The existing version of the TB-TST app has the following functionalities: it offers education on TB and its treatment, communication with a care-coordinator, tracks treatment adherence (both by self-reporting and direct metabolite test strip images), self-reports treatment side-effects, and retains patient's “diary” notes. The results from the pilot test of this version will be the starting point for this proposed study. Aims are to: 1) Refine the TB-TST intervention based on pilot study findings and apply principles of user-centered design; 2) Evaluate the impact of the TB-TST on treatment outcomes (success, default) compared to usual care; 3) Assess patient and provider perceptions of the facilitators and barriers to implementation of the TB-TST and synthesize lessons learned with stakeholders and policy makers. The primary outcome will be treatment success. Secondary outcomes will include: treatment default rates, self-reported adherence, technology use and usability. Findings have broader implications not only for TB adherence but disease management more generally and will improve our understanding of how to support patients facing challenging treatment regimens.